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location: West Point, Pennsylvania
job type: Contract
salary: $48.56 - 57.14 per hour
work hours: 9 to 5
Performs the calibration and validation of test and data analysis equipment and systems used for clinical research, trials and product testing. Assists in equipment selection, specification and negotiation of competitive pricing. Maintains all documentation pertaining to qualification and validation. May develop procedures and/or protocols. Also serves as information resource for validation technicians, contractors and vendors. This role is intended for use by companies in the Life Sciences and Medical Device industries and should be used for those individuals validating results for clinical research, clinical trials and manufacturing testing.
- Support Compliance Projects and Programs
- Design, Author, and Execute Computerized System Validation (CSV) - according to GAMP 5 guidance - especially on Analytical Laboratory Test Equipment and other Lab Information Systems
- Technical Writing of Validation Documents (Risk Assessment, Validation Plan, Design Configuration/Specification, User Requirements, Functional Requirements, IQ OQ PQ, Trace Matrix, Validation Summary Report), SOPs, Maintenance Procedures, Calibration Procedures, and other instrument support documents
- Translate technical information and requirements into qualification/validation test design
- Contribute to the overall growth of our compliance business
- Bachelor's Degree; scientific background preferred
- At least 3-5 years of pharmaceutical of FDA related validation experience
- Good knowledge of GMPs, 21CFR Part 11, USP 1058 - and other relevant industry regulations and guidance
- Strong interpersonal skills and demonstrated ability work independently
- Organized and task oriented
- Excellent written and oral communication skills - especially on technical topics
- Self-directed and motivated individual who is able to operate in a rapidly changing business environment
- Customer-oriented, conducting job function with a primary focus on customer satisfaction (internal & external) and ability to deal with customer complaints
- Must have a strong command of Microsoft Office Word and Excel and Adobe Acrobat, Microsoft Project
- Ability to build consensus among team of stakeholders
- Excellent critical thinking/analytical and problem solving skills
skills: FDA, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.